MedTrace Logo

Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

NCT00842907 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-06-08

No results posted yet for this study

Summary

This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.

Conditions

  • Photodamage
  • Photoaging

Interventions

DRUG

oral isotretinoin

one 20.0 mg capsule, once a day, every other day, during 24 weeks

DRUG

Tretinoin

0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Edileia Bagatin, MD, PhD · Federal University of Sao Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-12-31
Completion
2010-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00842907 on ClinicalTrials.gov